In a significant leap forward for orthopedic and spine technology, SurGenTec, a leading medical device company, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative B-MAN Bone Marrow Aspirate Kit. This clearance marks a pivotal moment in the evolution of bone marrow aspiration, offering a centrifuge-free solution designed to […]
Akili, Inc. (Nasdaq: AKLI), a leader in digital therapeutics, has announced a significant breakthrough with the U.S. Food and Drug Administration (FDA) clearance of its latest product, EndeavorOTC (AKL-T01), for adults with attention-deficit/hyperactivity disorder (ADHD). This groundbreaking development marks EndeavorOTC as the first FDA-authorized digital therapeutic for ADHD that is available over the counter. Tailored […]
Outset Medical, Inc., a leader in innovative medical technology, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its new product, TabloCart with prefiltration. This accessory is designed to enhance the functionality of the Tablo Hemodialysis System, already known for its revolutionary approach to dialysis by reducing the procedure’s […]
In a significant development for the medical technology sector, Getinge has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Vasoview Hemopro 3, marking a pivotal moment in the advancement of endoscopic vessel harvesting (EVH) solutions. This clearance underscores Getinge’s adherence to the highest standards of safety and effectiveness, […]
The UCART19 lymphoblastic leukemia drug jointly developed by Servier and Pfizer has been given the FDA clearance for its clinical development for lymphoblastic leukemia treatment.
Servier and Pfizer Inc. have received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to proceed with the clinical development of UCART19, an innovative gene-edited therapy for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL). Groundbreaking Gene-Edited Therapy UCART19, a chimeric antigen receptor (CAR) T-cell therapy, targets CD19-expressing hematological malignancies […]